An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects

Inclusion criteria

• Subjects having understood and signed an informed consent form.
• Either sex
• Healthy subjects, 18 to 65 years of age
• Subjects with skin types I to IV according to Fitzpatrick Scale
• Subjects without erythema on test areas on the mid back skin (visual irritation score = 0) at baseline (Day 1), before randomisation.

Exclusion criteria

• Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
• Any topical or systemic corticosteroids or immuno-suppressors within 3 weeks prior to randomisation
• Any other medication which may interfere with the study results, in particular topical drugs applied on the test area within 2 weeks prior to randomisation
• Any other products which may interfere with the study results, in particular emollients, creams, gels, lotions and body powders applied on the test area within 24 hours prior to randomisation
• Any systemic or cutaneous disease that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
• Scars, moles, sunburn, or other blemishes in the test area which may interfere with grading
• Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 2 weeks prior to randomisation or is planned during the study period
• Known or suspected hypersensitivity to any component of the investigational products
• Participation in any other interventional clinical trial within 4 weeks prior to randomisation or during the study period, based on interview of the subject